MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. MAXCORE; BIOPSY INSTRUMENT

Model Number	MC2020
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Event or Problem Description
This report summarizes three malfunctions.A review of the reported malfunctions indicated that model mc2020 biopsy instrument allegedly experienced unsealed device packaging.These reports were received from various sources.All three malfunctions did not involve with patients as there was no patient contact.The patients' age, gender and weight were not provided for all three malfunctions.

• Brand Name: MAXCORE
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 10314975
• Report Number: 2020394-2020-05003
• Device Sequence Number: 1072576
• Product Code: KNW
• UDI-Device Identifier: 00801741084522
• UDI-Public: (01)00801741084522
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: MC2020
• Device Catalogue Number: MC2020
• Device Lot Number: REBU0034, REBT2183, RECW1765
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 07/23/2020
• Patient Sequence Number: 1